Jinfukang Oral Liquid Combined With Chemotherapy for Treating Driver Gene-negative Advanced NSCLC

China Resources Sanjiu Medical & Pharmaceutical

Status and phase: Not yet enrolling; Phase 4

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Jinfukang oral liquid; Drug: Platinum-based doublet chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT05098990

ICM-JFK-CR01

Details and patient eligibility

About

This is a prospective, randomized, multicenter real-world study, which aims to investigate the efficacy and safety of Jinfukang oral liquid combined with chemotherapy as first-line treatment regimen for patients with driver-negative advanced NSCLC. 328 patients with unresectable stage IIIB-IV NSCLC and Qi-Yin deficiency will be divided into experimental (n=164) and control groups (n=164) according to the stratified blocked randomization.

Enrollment: 328 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18-80 years of age;
2. Patients with stage ⅢB-IV NSCLC are diagnosed by histopathology and cytology;
3. Patients' tumor tissues are unresectable as assessed by the investigator;
4. Have measurable disease based on RECIST 1.1;
5. Driver gene (EGFR/ALK/ROS1) is negative;
6. Patients who are receiving first-line platinum-doublet chemotherapy with remaining no fewer than 4 therapeutic cycles;
7. Patients in chemotherapy who combined with other systemic therapy (including but not limited to immune checkpoint inhibitors and anti-vascular targeted drugs) are not suitable, but with radiotherapy can be permitted;
8. During chemotherapy cycles, patients who take prior treatment with anticancer Chinese medicine less than 4 weeks can be enrolled after stopping medication. If administration time is longer than 4 weeks, at least 4 weeks washout period should be performed;
9. Patients are diagnosed with Qi-yin deficiency by the Syndrome Differentiation of Traditional Chinese Medicine;
10. The expected survival time ≥3 months;
11. The subjects volunteer to sign the informed consent.

Exclusion criteria

1. Allergy or hypersensitivity to ingredients of the study treatment formulation;
2. Pregnant or lactating women;
3. Patients with multiple brain metastases, multiple bone metastases and liver metastases, which have great influence on survival times；
4. Patients are enrolling in other therapeutic trials;
5. The investigator does not consider the participant to be eligible for this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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328 participants in 2 patient groups

Jinfukang oral liquid+Platinum-based doublet chemotherapy

Experimental group

Description:

The usage cycle of Jinfukang oral liquid will be consistent with platinum-based doublet chemotherapy. Jinfukang oral liquid will be taken at day 5 after chemotherapy, and will be taken continuously 3 times per day and 30 mL per time at least 4 cycles. The usage of platinum-based doublet chemotherapy will be performed following the details described at the "Primary Lung Cancer Diagnosis and Treatment Guidelines" and "Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Non-small Cell Lung Cancer".

Treatment:

Drug: Jinfukang oral liquid

Platinum-based doublet chemotherapy

Active Comparator group

Description:

The usage of platinum-based doublet chemotherapy will be performed following the details described at the "Primary Lung Cancer Diagnosis and Treatment Guidelines" and "Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Non-small Cell Lung Cancer".

Treatment:

Drug: Platinum-based doublet chemotherapy